Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 6:35 PM
Study NCT ID:
NCT00003433
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-11', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-08-12', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'liver metastases'], 'conditions': ['Colorectal Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to kill their tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with resected liver metastases from colon cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the cellular immune response to carcinoembryonic antigen pulsed dendritic cells in patients with adenocarcinoma of the colon metastatic to the liver.\n* Evaluate the overall and recurrence free survival in this patient population.\n\nOUTLINE: Patients undergo leukapheresis for up to 4.5 hours to collect dendritic cells. The separated dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Patients receive CEA RNA pulsed dendritic cells intravenously every 2 weeks for a total of 4 doses. Patients undergo a second leukapheresis 2 weeks after the last dendritic cell infusion to obtain specimens for immunologic tests. Patients with extra doses of dendritic cells available may receive additional doses of CEA RNA pulsed dendritic cells every 2 months in the absence of unacceptable toxicity.\n\nPatients are followed at weeks 12, 24, 36, and 48, and every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 22 patients will be accrued for this study over 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon metastatic to the liver that expresses carcinoembryonic antigen (CEA) after resection with curative intent\n\n * At least 50% of the tumor cells must stain positive for CEA with at least moderate intensity\n* No gross residual disease after surgery\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* Greater than 6 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1000/mm 3\n* Hemoglobin at least 9 g/dL\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL\n* No chronic or acute hepatic disease\n\nRenal:\n\n* Creatinine less than 2.5 mg/dL\n\nCardiovascular:\n\n* No chronic or acute cardiac disease (New York Heart Association class III or IV)\n\nPulmonary:\n\n* No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease\n\nOther:\n\n* Not pregnant or nursing\n* No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years\n* No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis\n* No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis\n* No active infectious enteritis or eosinophilic enteritis\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No other concurrent immunotherapy\n\nChemotherapy:\n\n* No concurrent chemotherapy\n* At least 6 weeks since prior chemotherapy\n\nEndocrine therapy:\n\n* No concurrent steroid therapy (or any other immunosuppressives)\n* At least 6 weeks since prior steroid therapy\n\nRadiotherapy:\n\n* No concurrent radiotherapy\n* At least 6 weeks since prior radiotherapy\n\nSurgery:\n\n* Recovered from prior surgery'}, 'identificationModule': {'nctId': 'NCT00003433', 'briefTitle': 'Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous, Cultured Dendritic Cells After Complete Resection of Hepatic Metastases of Colorectal Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000066459'}, 'secondaryIdInfos': [{'id': 'DUMC-2031-00-11R3'}, {'id': 'DUMC-2176-99-12R2'}, {'id': 'DUMC-97146'}, {'id': 'NCI-G98-1456'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carcinoembryonic antigen RNA-pulsed DC cancer vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Herbert K. Lyerly, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}